K970654 is an FDA 510(k) clearance for the CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER). This device is classified as a Hemodialyzer, Re-use, Low Flux (Class II - Special Controls, product code MSE).
Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on November 12, 1997, 264 days after receiving the submission on February 21, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K970654 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 1997 |
| Decision Date | November 12, 1997 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MSE — Hemodialyzer, Re-use, Low Flux |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |